Liver CancerPhase 1/2NCT00614913
Proton Beam Therapy for Treatment of Hepatocellular Carcinoma
A Phase 1/2 study testing Proton radiation therapy in people with Liver Cancer and Hepatocellular Carcinoma, run by Loma Linda University at 1 site in United States.
Trial summary
This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma
- What is being tested?
- Proton radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- May 1998to Feb 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hepatocellular carcinoma
- Adult patients aged 18 years old and above
- Ability to give informed consent for study
- Compensated liver disease
Who cannot join
- Pediatric patients (aged less than 18 years old)
- Decompensated or advanced liver disease
- Poorly controlled ascites
- Variceal hemorrhage within the previous 30 days
- Recurrent hepatic encephalopathy
- Cirrhosis with CTP* score >10
Show all 12Show fewer
- Active alcohol or drug abuse
- Anticipated survival of less than 30 days
- Advanced co-morbid medical illnesses
- Karnofsky Performance Score <60
- Tumor characteristics:
- Any tumor that can not be safely and effectively irradiated due to inability to deliver target treatment dose to required treatment volume or due to prohibitively high risk of anticipated toxicities to normal liver or nearby bowel, stomach, kidney or spinal cord.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center / James M. Slater Proton Treatment Center
Loma Linda, California, 92354
About this study
Official title: Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma
This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.
Read the detailed description
Hepatocellular carcinoma (HCC) is a type of primary cancer of the liver that is being diagnosed in the U.S. population with increasing frequency. While surgery is the first line of treatment, many patients are not eligible for surgical removal. Current non-surgical treatments for HCC are not fully effective and can have substantial side-effects. This study utilizes a type of radiation treatment called proton beam that can deliver high doses of radiotherapy to tumors within the liver while minimizing damage to surrounding healthy tissues. The treatment is non-invasive and is given on an out-patient basis over a three week coarse. The study will evaluate the effectiveness and side-effects of this therapy by tracking patient's outcomes following treatment.
- Conditions
- Liver Cancer, Hepatocellular Carcinoma
- Being tested
- Proton radiation therapy
- Keywords
- Proton, Radiotherapy, Hepatocellular carcinoma, Liver Cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton radiation therapyRadiation
A total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
Percent of participants alive and without tumor progression 3 years following treatment.
Measured: 3 months
Median Survival Without Tumor Progression
Median time until disease progression or death
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMay 1998
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Bush, Loma Linda University
- Investigators
- David A Bush, MD, Principal investigator, Loma Linda University Dept. of Radiation MedicineJerry D Slater, MD, Study chair, Loma Linda University Department of Radiation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614913
- Sponsor's protocol ID
- OSR #48095
- Status last verified
- Jul 2012
- First submitted
- 26 Dec 2007
- Last updated
- 20 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-dose proton beam radiotherapy of hepatocellular carcinoma: preliminary results of a phase II trial. Gastroenterology. 2004 Nov;127(5 Suppl 1):S189-93. doi: 10.1053/j.gastro.2004.09.033.
PubMed 15508084Bush DA, Kayali Z, Grove R, Slater JD. The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Cancer. 2011 Jul 1;117(13):3053-9. doi: 10.1002/cncr.25809. Epub 2011 Jan 24.
PubMed 21264826
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Proton Beam Therapy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00614913
- Acronym / sponsor ID
- OSR #48095
- Conditions
- Liver Cancer, Hepatocellular Carcinoma
- Keywords
- Proton, Radiotherapy, Hepatocellular carcinoma, Liver Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- May 1998
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 20 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.
Detailed description
Hepatocellular carcinoma (HCC) is a type of primary cancer of the liver that is being diagnosed in the U.S. population with increasing frequency. While surgery is the first line of treatment, many patients are not eligible for surgical removal. Current non-surgical treatments for HCC are not fully effective and can have substantial side-effects. This study utilizes a type of radiation treatment called proton beam that can deliver high doses of radiotherapy to tumors within the liver while minimizing damage to surrounding healthy tissues. The treatment is non-invasive and is given on an out-patient basis over a three week coarse. The study will evaluate the effectiveness and side-effects of this therapy by tracking patient's outcomes following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of hepatocellular carcinoma
- Adult patients aged 18 years old and above
- Ability to give informed consent for study
- Compensated liver disease
Key exclusion criteria (12 listed)
- Pediatric patients (aged less than 18 years old)
- Decompensated or advanced liver disease
- Poorly controlled ascites
- Variceal hemorrhage within the previous 30 days
- Recurrent hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton radiation therapyA total dose of 63 Gy will be delivered in 15 equally divided daily fractions over a 3 week coarse as an out-patient. | Radiation | – |
Primary outcome
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria
Time frame: 3 months
Percent of participants alive and without tumor progression 3 years following treatment.
Median Survival Without Tumor Progression
Time frame: 3 months
Median time until disease progression or death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15508084Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-dose proton beam radiotherapy of hepatocellular carcinoma: preliminary results of a phase II trial. Gastroenterology. 2004 Nov;127(5 Suppl 1):S189-93. doi: 10.1053/j.gastro.2004.09.033.
- Results publication: PubMed 21264826Bush DA, Kayali Z, Grove R, Slater JD. The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Cancer. 2011 Jul 1;117(13):3053-9. doi: 10.1002/cncr.25809. Epub 2011 Jan 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Bush, MD principal investigator
Loma Linda University Dept. of Radiation Medicine
Jerry D Slater, MD study chair
Loma Linda University Department of Radiation Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Proton radiation therapy in people with Liver Cancer and Hepatocellular Carcinoma, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00614913, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2012.